Device, system, and method for transcatheter treatment of valve regurgitation
Inventors
Khairkhahan, Alexander • Lesh, Michael D.
Assignees
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Publication Number
US-11678986-B2
Publication Date
2023-06-20
Expiration Date
Abstract
The invention relates to a device for use in the transcatheter treatment of mitral valve regurgitation, specifically a coaptation enhancement element for implantation across the valve; a system including the coaptation enhancement element and anchors for implantation; a system including the coaptation enhancement element, catheter and driver; and a method for transcatheter implantation of a coaptation element across a heart valve.
Core Innovation
A coaptation implant system includes a coaptation implant with a coaptation surface configured for an anterior leaflet of a valve to coapt against. The implant includes a superior edge, lateral edges, and an inferior edge, where a distance between the lateral edges generally decreases toward the inferior edge, and the implant also includes a hub and at least one strut extending from the hub.
A helical anchor is configured to be rotated relative to the hub to engage tissue. The coaptation implant surface is configured to balloon or stretch toward the left atrium during systole, while the helical anchor remains unmoved, and the coaptation implant system is configured to experience some motion and deformation as surrounding cardiac structures move in relation to one another during the cardiac cycle.
The implant system is further configured such that a superior portion of the coaptation zone closely replicates native leaflet motion during systole. The system provides functional coaptation such that communication between the atrium and ventricle is sealed by coaptation of the anterior leaflet against the coaptation implant, and the coaptation implant is described as functionally replacing the posterior leaflet.
Claims Coverage
The patent includes three independent claims that share a common implant architecture and differ in how motion and deformation during the cardiac cycle are configured. Across the independent claims, three main inventive aspects appear: systolic ballooning or stretching toward the left atrium with a rotatable helical anchor that remains unmoved, configuration to experience motion and deformation as surrounding cardiac structures move, and close replication of native leaflet motion in a superior portion through the coaptation zone during systole.
Systolic ballooning or stretching toward the left atrium
A coaptation implant comprising a coaptation surface configured for an anterior leaflet to coapt against, a superior edge, lateral edges and an inferior edge where a distance between the lateral edges generally decreases toward the inferior edge, a hub, at least one strut extending from the hub, and a helical anchor configured to be rotated relative to the hub to engage tissue, wherein a surface of the coaptation implant is configured to balloon or stretch toward the left atrium during systole while the helical anchor remains unmoved.
Motion and deformation during the cardiac cycle
A coaptation implant system comprising a coaptation implant with a coaptation surface configured for an anterior leaflet to coapt against, a superior edge, lateral edges and an inferior edge where a distance between the lateral edges generally decreases toward the inferior edge, a hub, at least one strut extending from the hub, and a helical anchor configured to be rotated relative to the hub, wherein the coaptation implant is configured to experience some motion and deformation as surrounding cardiac structures move in relation to one another during the cardiac cycle.
Closely replicating native leaflet motion through the coaptation zone
A coaptation implant system comprising a coaptation implant with a coaptation surface configured for an anterior leaflet to coapt against, a superior edge, lateral edges and an inferior edge where a distance between the lateral edges generally decreases toward the inferior edge, a hub, at least two struts, and a helical anchor configured to be rotated relative to the hub to engage tissue, wherein a superior portion of the coaptation implant through a coaptation zone is configured to closely replicate the motion of a native leaflet during systole.
Across the independent claims, the claim coverage focuses on a coaptation implant architecture with a coaptation surface, decreasing lateral-edge distance toward the inferior edge, a hub, struts, and a rotatable helical anchor, combined with systolic motion behavior that includes ballooning or stretching, motion and deformation, and close replication of native leaflet motion.
Stated Advantages
Seals communication between the atrium and ventricle.
Allows relatively normal blood circulation in the ventricular chamber.
Functionally replaces the posterior leaflet.
Avoiding annular reshaping or leaflet fusion is emphasized in the provided description text.
Enables less skill-dependent, less invasive deployment is emphasized in the provided description text.
Documented Applications
Transcatheter treatment of mitral valve regurgitation using a coaptation enhancement/assist implant deployed across the mitral valve plane.
Mitral valve leaflet coaptation that creates an artificial coaptation zone so the native anterior leaflet coapts against the implant and mitigates mal-coaptation.
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